New Performance Measures for Peripheral Artery Disease Issued Reply

Performance measures to improve the diagnosis and treatment of peripheral artery disease (PAD) in adults have been published for the first time. The document was produced by the ACC, the AHA, and several other medical organizations. Here are a few key details of the performance measures:
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Study Finds No Link Between Cancer and Antihypertensives, Except for ARB-ACE Inhibitor Combo Reply

A new meta-analysis has found no evidence of a large cancer risk for most common antihypertensive agents, but did find strong evidence, largely based on one trial, for at least a 10% increase in cancer risk with the rarely used angiotensin-converting-enzyme (ACE) inhibitor and angiotensin-receptor blocker (ARB) combination. In a paper in the Lancet Oncology, Sripal Bangalore and colleagues report on multiple analyses of data taken from 70 trials and including almost 325,000 patients.
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MARINE: New Fish Oil Pill Slashes High Triglycerides Reply

A new prescription-grade formulation of ethyl-EPA, an omega-3 fatty acid, significantly lowers triglycerides but doesn’t increase LDL. These were the top line results of the MARINE trial released on Monday by Amarin Corporation, which is developing the drug, now known as AMR101.

MARINE randomized 229 patients with triglyceride levels of 500 mg/dl or greater to placebo or 2 mg or 4 mg of AMR101. Approximately 25% of patients were taking statins. The company said the trial was the largest therapeutic trial in patients with high triglycerides and that it plans to submit an NDA to the FDA in 2011.
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Greek Study Offers Reassurance About Statin Usage in Patients with Abnormal Liver Tests 3

Among the 1600 patients randomized in the GREACE (Greek Atorvastatin and Coronary Heart Disease Evaluation) study, 437 had moderately abnormal liver tests at baseline suggesting non-alcoholic fatty liver disease (NAFLD).

In a post-hoc analysis of this subset of patients published in the Lancet, the GREACE Study Collaborative Group reported a dramatic 68% reduction in the rate of cardiovascular events in patients in the statin group. Cardiovascular events occurred in 30% of patients in the non-statin group (63 out of 210) compared to 10% of patients in the statin group (22 of 227). The authors say their results mean that “statin treatment is safe and can improve liver tests and reduce cardiovascular morbidity in patients with mild-to-moderately abnormal liver tests that are potentially attributable to non-alcoholic fatty liver disease.” In addition, the authors note that statin treatment was associated with improvement in liver tests.
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Guest Post: Of Drug Talks, Deception, and Denial 2

This guest post by Roy Poses, MD, is reprinted with permission from Health Care Renewal.

by Roy M. Poses, MD

A month ago, we discussed a series of reports by Pro Publica and multiple other respected news organizations about payments by seven pharmaceutical companies to thousands of doctors.  Industry often claims that they only pay the best and the brightest physicians and academics to provide education relevant to their products.  However, the ProPublica et al report suggested that they mainly recruited physicians who already showed their favor to their products by prescribing them often, but soothed their consciences by dubbing them “thought leaders” or “key opinion leaders.”  While some of the physicians were well-known academics, others had notably blemished records.

Since then, a series of local or regional news organizations have reported on physicians in their areas.  These reports (all listed below as “references” in somewhat chronological order ) further explained how these “drug talks” are just marketing exercises, and how some of the physicians involved rationalized making money hawking drugs.
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SHARP: A Tale of Two Press Releases 2

Two press releases were issued about the SHARP trial : one from Merck, the much-maligned and criticized manufacturer of Vytorin (the combination of ezetimibe and simvastatin), and one from the group running the trial, the highly-respected Clinical Trials Service Unit (CTSU) at Oxford. Here’s the surprise: compared to the Oxford press reelease, the Merck release is a paragon, fully disclosing important details about the trial. The Oxford release is also a paragon, but of a different type. It’s a model of a press release that tries to manipulate the reader to adopt its view of the trial and ruthlessly suppresses all information and perspective that doesn’t support its view.

Let’s review the deficiencies of the Oxford press release:
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SHARP Shows Benefit for Vytorin in Chronic Kidney Disease 3

The long-awaited SHARP study has turned up positive results for Vytorin (ezetimibe and simvastatin) in a population of patients with chronic kidney disease. Results of SHARP (Study of Heart and Renal Protection) were presented on Saturday at the American Society of Nephrology meeting in Denver and were scheduled to be posted online on the trial’s website.

SHARP compared Vytorin to placebo in  9,438 patients with chronic kidney disease and found that Vytorin-treated patients had a significant (p=0.0010) 16.1% reduction in the incidence of first major vascular event ( nonfatal MI or cardiac death, stroke, or revascularization). A first major vascular event occurred in 15.2% of patients in the Vytorin group compared to 17.9% of patients in the placebo group.
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APPRAISE-2 Apixaban in ACS Study Discontinued Due to Increased Bleeding Reply

Bristol-Myers Squibb announced on Thursday evening the discontinuation of APPRAISE-2 (Apixaban for Prevention of Acute Ischemic Events – 2), a phase 3 trial comparing apixaban to placebo in patients with acute coronary syndrome. The decision was based on a recommendation from the Data Monitoring Committee based on “a clinically important increase in bleeding among patients randomized to apixaban,” according to the company press release. APPRAISE-2 is one a series of clinical trials studying the anticoagulant apixaban in a variety of patient populations.

Robert Harrington, the co-chair of the APPRAISE-2 steering committee, provided some perspective on the news for CardioBrief. He said that APPRAISE 2 enrolled a high risk group of ACS patients and that most, though not all patients were already receiving dual antiplatelet therapy (DAPT). By contrast, patients in anticoagulant trials for AF and DVT do not usually take DAPT. It should also be noted that, according to Harrington, warfarin plus DAPT has been associated with increased bleeding, but this has not been the subject of a randomized trial.

It should be noted that rivaroxaban and dabigatran are also now being studied in the setting of ACS. In the BMS press release Harrington said that the decision about APPRAISE-2 should not impact the “promising results” in phase 3 trials of apixaban in patients with VTE and AF.

Click here to read the press release form Bristol-Myers Squibb…

Will This Be the HDL Decade? REVEAL Revealed, Mixed Results for Apo-A1 1

For a long time HDL has been called the “good cholesterol.” Are we now entering the HDL decade? Two HDL-related trials were presented today at the AHA, and an array of additional trials are planned or underway, prompting the  lead investigator of one of those trials, Chris Cannon, to speculate that this decade may be the HDL decade.

Whether or not the 2010s turn out to be the HDL decade, there can be no question that today was HDL day. In addition to the excitement generated by Cannon’s trial, DEFINE, Merck and Oxford announced a major mega-trial to test the drug used in that trial, anacetrapib, in 30,000 patients. Less easy to interpret were the results of a small study, ASSERT, looking at a novel compound and it’s ability to boost HDL.
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Anacetrapib: “knock-your-socks-off effect on HDL and a jaw-dropping effect on LDL” 3

Following the failure of torcetrapib in 2006 the future of CETP inhibitors appeared quite troubled. Now, with the results of  DEFINE (Determining the Efficacy and Tolerability of CETP Inhibition with Anacetrapib), presented at the AHA in Chicago and published online simultaneously in the New England Journal of Medicine, the future for this novel class of drugs appears much brighter, but the final decision about anacetrapib will have to wait for a larger clinical trial.
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CardioExchange at the AHA: A New Voice Emerges Reply

Some of you may be aware that my “day job” for the last year has been with the Massachusetts Medical Society, publishers of NEJM. I’ve been working with the great people at MMS helping develop and publish CardioExchange, a social media website for cardiovascular healthcare professionals. Now that may sound silly to many of you (and it did to me at first) because most cardiologists are the last people on earth you’d expect to see “friending” each other on Facebook.

But those guys in Massachusetts are smart. They recognized that the traditional model of medical communications– embodied most notably, of course, by the august and magnificent NEJM itself– might not have the same impact as it has in the past, and certainly its role would be tested by all sorts of newer, alternative communication models.
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BASKET-PROVE Examines Stents for Large Vessels Reply

The BASKET investigators continue their investigator-led exploration of stents in the real world. In BASKET-PROVE they sought to test the hypothesis derived from observations in earlier trials that drug-eluting stents in large vessles might cause only a marginal reduction in revascularizations and might have an increased risk for late stent thrombosis.

The results of BASKET-PROVE were presented today at the AHA and published simultaneously in the New England Journal of Medicine. The trial randomized 2314 patients needing stents 3.0 mm or larger to receive either a sirolimus-eluting, an everolimus-eluting, or bare-metal stent.
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GRAVITAS: No Benefit for Clopidogrel Dosing Based on Platelet Function Test 1

The GRAVITAS (Gauging Responsiveness With A VerifyNow Assay– Impact on Thrombosis and Safety) trial enrolled 2,214 patients with high residual platelet reactivty, as assessed by the VerifyNow P2Y12 Test measured 12 to 24 hours after the procedure. (The manufacturer of the test, Accumetrics, sponsored the trial.) Patients in the trial were randomized to either high dose clopidogrel (additional loading dose, 150 mg daily thereafter) or standard-dose clopidogrel (no additional loading dose, 75 mg daily thereafter).
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Blast Off! ROCKET AF Hits Chicago 4

ROCKET AF hit the AHA on Monday morning. Results of ROCKET AF (Stroke Prevention Using the Oral Direct Factor Xa Inhibitor Rivaroxaban Compared With Warfarin in Patients with Nonvalvular Atrial Fibrillation) had been the topic of intense speculation and interest.

The trial showed that the experimental factor Xa inhibitor rivaroxaban was as effective as warfarin in preventing stroke in 14,264 AF patients and did not increase their risk of bleeding. In the per protocol analysis, the rate of stroke and embolism was lower in the rivaroxaban group than in the warfarin group (p<0.001 for non-inferiority, p=0.018 for superiority). Major bleeding complications occurred at a similar rate (p=0.576).
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Omega-3 Fails to Show Benefits in Atrial Fibrillation 2

In sharp contrast to earlier studies suggesting a positive effect, a large study of high dose prescription omega-3 fatty acids found no evidence of benefit in treating atrial fibrillation. The trial, called the Efficacy and Safety of Prescription Omega-3 Acid Ethyl Esters (P-OM3) for the Prevention of Recurrent Symptomatic Atrial Fibrillation, included 663 patients with AF (542 with paroxysmal AF and 121 with persistent AF). Patients were randomized for 24 weeks to either placebo or a prescription formulation of high dose omega- 3 fatty acids (8 grams/day for the first week, 4 grams/day thereafter).
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Drinking in ASCEND: Is the Cup Half Empty or Half Full? Reply

Generally I’m a half-empty kind of guy. Even if the cup is maybe 60% full I still see it as half empty. But I must say that today I’m actually quite encouraged by ASCEND.

Others disagree. NPR health blogger Scott Hensley tweeted this about ASCEND today:

As usual, info is yrs too late.

And of course, he’s right. Hensley also cited a story he wrote for the Wall Street Journal back in 2006 featuring Steve Nissen criticizing the delays in starting the ASCEND trial. It’s a good point.

But the message today should be something different, IMO. I’m actually encouraged that we’ve received a final, definitive answer to this controversial topic in less than a decade after Nissen and then Sackner-Bernstein first raised concerns about nesiritide in 2003. I know that many think we can and should do better. But for now I take comfort that at least one of these huge, swirling controversies has finally been resolved.


New LVAD Shows Promise as Bridge-to-Transplant Reply

ADVANCE (Evaluation of the HeartWare HVAD Left Ventricular Assist Device System for the Treatment of Advanced Heart Failure) evaluated the clinical efficacy of a novel small centrifugal flow pump as a bridge-to-transplant. In the trial, 140 patients who received the device were compared to a contemporaneous conrol group of 499 similar patients who had received a commercially available LVAD as a bridge-to-transplant. Results of ADVANCE were presented on Sunday at the AHA in Chicago.
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AHA: ASCEND Trial Finally Resolves the Nesiritide Controversy 2

In the end everyone was wrong. After many years of controversy, we finally know the truth about nesiritide, and all the experts were wrong. Steve Nissen and Jonathan Sackner-Bernstein, who first raised concerns about the safety of nesiritide in decompensated heart failure, turned out to be wrong. But the defenders of nesiritide, including its manufacturer, Johnson & Johnson, and James Young, the principle investigator of the drug’s pivotal trial, also turned out to be wrong. In the end nesiritide turned out to be safe. But it also turned out that it didn’t have any significant benefit.

In response to the enormous enormous controversy, which began back in 2003, the ASCEND-HF (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure Trial) was eventually started. The trial randomized 7,141 patients with acute, decompensated heart failure to receive standard therapy and either continuous intravenous nesiritide or placebo.
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Emphatic Support for Eplerenone in NYHA class II HF Reply

Aldosterone antagonists have proven beneficial in heart failure patients with moderate to severe symptoms and in MI patients with LV dysfunction and heart failure. Now the EMPHASIS-HF (Eplerenone in Mild Patients Hospitalization and Survival Study in Heart Failure) has extended these benefits to patients with systolic heart failure patients and mild symptoms.

EMPHASIS HF randomized 2737 patients with NYHA class II HF and an EF not over 35% to receive eplerenone or placebo in addition to standard therapy. The trial, which was presented at the AHA in Chicago and published simultaneously in the New England Journal of Medicine, was stopped early after 21 months. The rate of cardiovascular death or heart failure hospitalization was reduced from 25.9% in the placebo group to 18.3% in the eplerenone group (P<0.001). Total mortality was reduced from 15.5% to 12.5% (p<0.001). Hyperkalemia occurred significantly more often in the eplerenone group.
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ICD-CRT Found Beneficial in RAFT Reply

RAFT (Resynchronization-Defibrillation for Ambulatory Heart Failure Trial) randomized 1798 patients with NYHA class II or III heart failure, LVEF < 30%, and a wide QRS complex to either an ICD alone or an ICD-CRT. After a mean followup of 40 months, the rate of death or heart failure hospitalization was reduced from 40.3% in the ICD group to 33.2% in the ICD-CRT group (p<0.001). Overall mortality was reduced from 26.1% to 20.8% (p<0.003). There were more adverse events in the ICD-CRT group, however (124 versus 58 at 30 days). As in the MADIT-CRT trial, an increased benefit was observed in patients with QRS durations of 150 msec or more.
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